Medicament dispenser

ABSTRACT

A medicament dispenser for use in the storage, presentation and/or dispensing of medicament comprising a body shaped for receipt of a medicament container. In association with the body, there is a first transceiver for transmitting and receiving data. A medicament container is receivable by the body. In association with the medicament container, there is a second transceiver for transmitting and receiving data. Data is transferable in two-way fashion from the first transceiver to the second transceiver. The medicament dispenser may be supplied in kit of parts form.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.10,311,562, filed 16 Dec. 2002, now U.S. Pat. No. 7,191,777 which wasfiled pursuant to 35 USC 371 as a United States National PhaseApplication of International Patent Application Ser. No. PCT/EP01/07968filed 11 Jul. 2001, which claims priority from GB0017301.3 filed on 15Jul. 2000 in the United Kingdom, and GB0020538.5 filed on 22 Aug. 2000in the United Kingdom.

FIELD OF THE INVENTION

The present invention relates to a medicament dispenser for use in thedispensing of medicament. The medicament dispenser has a medicamentcontainer (e.g. in the form of a reloadable cartridge).

BACKGROUND OF THE INVENTION

Medical dispensers are well known for the dispensing of various kinds ofmedicament. Inhalation devices, such as metered dose inhalers (MDI) anddry powder inhalers are known for the delivery of medicament for thetreatment of respiratory disorders. Syringes, including needlelesssyringes are also known for the delivery of injectable medicament to apatient.

The manufacture of medical dispensers requires careful control to ensurecompliance with product specifications. Similarly, the packaging,distribution and sale of medical dispensers are carefully controlled toensure consistent product quality and security for the patient. It iscommon practice to mark the dispenser and any packaging therefore withvarious codings and serial numbers for use in checking productintegrity. Widely used marking techniques include the use of visualtext, machine-readable text, bar codes and dot codes.

In the event of a patient complaint which results in return of themedical dispenser or indeed in the event of a product recall for anyother reason, the manufacturer employs the codings and serial numbers tocheck the product details. Counterfeiting is known to be a problem withmedical dispensers given the often-high resale value of the product.Product marking is further employed to reduce the opportunities forcounterfeiting and in particular, to make counterfeit products morereadily identifiable.

Reloadable medicament dispensers are known. These typically comprise ahousing defining a cavity and a medicament container which is reversiblyreceivable thereby. The housing and the medicament container may be soldseparately or as a kit of parts. There is current interest in thedevelopment of reloadable medicament dispensers in which the housing isreasonably sophisticated in nature and comprises some sort of electronicdata management capability. The reload is desirably in the form of amedicament cartridge which for cost reasons has a relatively simpleform. The patient retains the sophisticated actuator housing and reloadsare inserted as required.

There are a number of potential challenges associated with reloadablemedicament dispensers and these have hitherto prevented their widespreaduse. A primary challenge is to ensure that the reload is employed withthe correct actuator housing. Secondary challenges include preventingthe use of out-of-date or counterfeit cartridge reloads. Tailoring theactuator housing to be only operable (e.g. mechanically operable) withthe correct reload is a feasible, but expensive and thereforecommercially unattractive solution to the primary challenge. Existingproduct marking methods can in some ways be employed to address thesecondary challenges. Overall, there is a need for further developmentsto address these and other challenges associated with reloadablemedicament dispensers.

SUMMARY OF THE INVENTION

The Applicants have now devised a solution for addressing the potentialchallenges associated with reloadable medicament dispensers which is ofgreater sophistication than presently used techniques and hassignificant advantages thereover. The solution involves associating afirst transceiver for transmitting and receiving a data signal with thereloadable actuator housing and associating a second transceiver withthe medicament container reload. The first and second transceivers arearranged such that data is transferable in two-way fashion (e.g.read/write fashion) therebetween. In typical embodiments, the firsttransceiver is an actively powered transceiver which forms an integralpart of an electronic data management system on the housing and thesecond transceiver is a passive (i.e. not directly powered) transceiver.Thus, the second transceiver may for example be a magnetic orradiofrequency identifier (RFID) label and the first transceiver areader therefor having read/write capability.

The transceiver on the medicament reload is typically marked at the timeof manufacture with various product information including type ofmedicament, initial number of doses, date and place of manufacture andan anti-counterfeiting code. If desired, further marking can be added atthe time of dispensing such as date and time of dispensing, name of theprescriber and pharmacist and identification of the patient. When thereload is inserted into the actuator housing, the marking thereon willbe read by the transceiver on the housing and the electronic datamanagement system updated. At this point, various security, productintegrity and product matching with actuator checks may be conducted(e.g. for out-of-date reloads or counterfeits) and any problems flagged.If product integrity problems are detected the dispenser mayautomatically shutdown.

An important aspect of the present development is that it allows fortwo-way transfer of data between the transceiver and electronic datamanagement system on the housing and the transceiver on the medicamentreload. This gives rise to significant advantages. For example, eachtime the medicament dispenser is used by the patient actuation ordispensing data may be recorded and transferred to the reload. The dosecount and other compliance data are therefore recordable by both theelectronic data management system of the housing and on the reload. Whenthe reload is removed from the housing, any subsequent insertion thereofcan be arranged to result in a re-recognition of the reload andassociated update of the electronic data management system. This can bearranged to operate even when multiple, possibly dissimilar, reloads areused with the same actuator housing. The development described hereintherefore enables a sophisticated actuator with electronic datamanagement capability to be used securely and intelligently withmultiple medicament reloads over a period of time. PCT patentapplication no. WO92/17231 describes a metered dose inhaler having amicroelectronic assembly thereon. The medicament container includes aset of electrically conducting strips which represent information aboutthe medicament container in digital form. The housing of the deviceincludes electrical contact fingers which are contactable with thestrips to enable reading of the information to a microelectronic memoryon the housing. Read/write communication would not be possible betweenthe fingers and the reader and the significant advantages of the presentinvention would therefore not be achievable with this inhaler.Furthermore, contact between the strips on the container and theelectrical contact fingers is required which requires physical tailoringof the container to the housing, thereby limiting product designoptions. This document also describes an embodiment in which an active(i.e. powered) microelectronic element is attached to the container.

According to one aspect of the present invention there is provided amedicament dispenser comprising a body, said body shaped for receipt ofa medicament container; in association with the body, a firsttransceiver for transmitting and receiving data; a medicament containerreceivable by the body; and in association with the medicamentcontainer, a second transceiver for transmitting and receiving data,wherein data is transferable in two-way fashion from the firsttransceiver to the second transceiver.

The medicament dispenser herein is suitable for use in the storageand/or presentation and/or dispensing of medicament.

The body is typically shaped to define a cavity within which themedicament container is receivable. The body and/or medicament containermay be further shaped with any manner of grooves, indentations or othershaping or surface details to define a ‘lock and key’ relationshipbetween the body and the container. Colour guides, arrows and any othersurface markings may also be employed.

The data is preferably in digital form and suitable for transfer by e.g.electronic or optical means. Data is transferable when the medicamentcontainer is received wholly or partly by the body. A defined datatransfer position in which there is specific registration between thebody and container received thereby may be established.

One advantage of the present invention is the ability to store manytypes of information in different parts of the memory structure of thetransceivers. The information is furthermore stored in a form which isreadily and accurately transferable.

The information could for example, include manufacturing anddistribution compliance information written to the memory at variouspoints in the manufacturing or distribution process, thereby providing adetailed and readily accessible product history of the dispenser. Suchproduct history information may, for example, be referred to in theevent of a product recall. The compliance information could, forexample, include date and time stamps. The information could alsoinclude a unique serial number stored in encrypted form or in a passwordprotectable part of the memory which uniquely identifies the product andtherefore may assist in the detection and prevention of counterfeiting.The information could also include basic product information such as thenature of the medicament and dosing information, customer informationsuch as the name of the intended customer, and distribution informationsuch as the intended product destination.

The information written to the memory may be provided in a particularlanguage (e.g. French, English) including a non-latin typescriptlanguage (e.g. Mandarin Chinese or Thai) or it may be provided inmultilingual form. In one aspect, the dispenser is provided with thecapability (e.g. by way of appropriate software) to display informationread from the medicament container in any selected language. In oneaspect, the information/language is defined by what is written to themedicament container (e.g. at the traditional point of labelling in themanufacturing process). The container then has the form of a geographyand/or language-specific product.

In another aspect, the medicament container has multi-geographic and /orlinguistic information written thereto (e.g. at the traditional point oflabelling point in the manufacturing process). The container then hasthe form of an ‘international’ product. The medicament dispenser maythen be configured (e.g. by the patient or by the pharmacist at the timeof prescribing) to read/display to the patient only thatinformation/language data set that is relevant to the particular market(or patient) of interest.

In a further aspect, the medicament container has information writtenthereto (e.g. at the traditional point of labelling in the manufacturingprocess) in a default (e.g. standard) language/character set. Thecontainer then has the form of a ‘standard’ product. The medicamentdispenser is then provided with the capability translate that standarddataset into any local format such that it displays to the patient onlythe information/language data set that is relevant to the particularmarket (or patient) of interest.

On loading or reloading the dispenser with a medicament container (suchas an aerosol canister or dry powder cassette) the second transceivermay, for example, read the unique serial number, batch code and expirydate of the medicament and any other information on the secondtransceiver. In this way the nature and concentration of the medicament,together with the number of doses used or remaining within thecontainer, may be determined. This information can be displayed to thepatient on a visual display unit. Other information, such as the numberof times the dispenser has been reloaded with a medicament container,may also be displayed.

Similarly, should the container be removed from the housing before thesupply of medicament is exhausted, the same data can be read from thesecond transceiver and the number of doses remaining or used determined.Other information, such as the date and time of administration of thedrug, or environmental exposure data such as the minimum/maximumtemperatures or levels of humidity the medicament container has beenexposed to, may also be read and displayed to the user.

In the event that the supply of medicament within the container becomesexhausted, or that the shelf life of the medicament has expired, or thatthe first transceiver does not recognise the batch code on the secondtransceiver, activation of the dispenser may be prevented to safeguardthe user. Activation may also be prevented if the medicament has beenexposed to extreme environmental conditions for periods outwith themanufacturer's guidelines.

Data may be transferred to and from any transceiver during the period ofuse of the medicament dispenser by the patient. For example, themedicament dispenser may include an electronic data management systemhaving various sensors associated therewith. Any data collected by thesensors or from any data collection system associated with theelectronic data management system including a clock or other date/timerecorder is transferable.

Data may be transferred each time the patient uses the device. Oralternatively, data may be stored in a database memory of the electronicdata management system and periodically downloaded to any transceiver.In either case, a history of the usage of the device may be built up inthe memory of a transceiver.

In one embodiment herein, a history of the usage of the medicamentdispenser is transferred to the second transceiver on the aerosolcontainer. When the medicament container is exhausted it is exchanged bythe patient for a new refill container. At the point of exchange, whichwill typically occur at the pharmacy, data may be transferred from theexhausted container to the refill and vice-versa. Additionally, usagehistory data may be read from the refill and transferred to a healthcaredata management system for example comprising a network computer systemunder the control of a healthcare data manager.

Methods are envisaged herein whereby the patient is given some sort ofreward for returning the refill and making available the data comprisedwithin the second transceiver. Methods are also envisaged herein wherebythe healthcare data manager is charged for either receipt of the datafrom the second transceiver or for its use for commercial purposes. Anyrewards or charging may be arranged electronically. The methods may beenabled by distributed or web-based computer network systems in whichany collected data is accessible through a hub on the network. The hubmay incorporate various security features to ensure patientconfidentiality and to allow selective access to information collecteddependent upon level of authorisation. The level of user authorisationmay be allocated primarily to safeguard patient confidentiality. Beyondthis the level of user authorisation may also be allocated on commercialterms with for example broader access to the database being authorisedin return for larger commercial payments.

Suitably, the first and second transceiver each comprise an antenna orequivalent for transmitting or receiving data and connecting thereto amemory. The antenna can, in embodiments, also transfer energy to thepassive receiver. The memory will typically comprise an integratedcircuit chip. Either transceiver may be configured to have a memorystructure which allows for large amounts of information to be storedthereon. The memory structure can be arranged such that parts of thememory are read-only, being programmed during/after manufacture, otherparts are read/write and further parts are password protectable. Initialtransfer of information (e.g. on manufacture or one dispensing) to orfrom any transceiver can be arranged to be readily achievable by the useof a reader which is remote from the medical dispenser, therebyminimising the need for direct product handling. In further aspects, thereader can be arranged to simultaneously read or write to the memory ofmultiple transceivers on multiple medicament dispensers.

A suitable power source such as a battery, clockwork energy store, solarcell, fuel cell, kinetics-driven cell or mains power supply (e.g. via asuitable transformer) will be provided as required to any electroniccomponent herein. The power source may be arranged to be rechargeable orreloadable. Suitably, data is transferable in two-way fashion betweenthe first and second transceiver without the need for direct physicalcontact therebetween. Preferably, data is transferable wirelesslybetween the first and second transceiver.

Suitably, the first transceiver is an active transceiver and the secondtransceiver is a passive transceiver. The term active is used to meandirectly-powered and the term passive is used to meanindirectly-powered.

Suitably, the second transceiver comprises a label or tag comprising anantenna for transmitting or receiving energy; and an integrated circuitchip connecting with said antenna, and the first transceiver comprises areader for said label or tag. In this case the label or tag is a passivetransceiver and the reader is an active transceiver. Preferably, thereader will not need to be in direct contact with the tag or label toenable the tag or label to be read.

The tag may be used in combination and/or integrated with othertraditional product labelling methods including visual text,machine-readable text, bar codes and dot codes.

Suitably, the integrated circuit chip has a read only memory area.

Suitably, the integrated circuit chip has a memory area with restrictedread access.

Suitably, the integrated circuit chip has a read/write memory area.

Suitably, the integrated circuit chip has a one-time programmable memoryarea. More preferably, the one-time programmable memory area contains aunique serial number.

Suitably, the integrated circuit chip has a preset memory areacontaining a factory preset, non-changeable, unique data item. Thepreset memory item is most preferably in encrypted form.

Suitably, the integrated circuit chip has plural memory areas thereon.

Suitably, any memory area contains data in encrypted form. Electronicmethods of checking identity, error detection and data transfer may alsobe employed.

Suitably, any memory area is password protected.

In one preferred aspect, the integrated circuit has plural memory areasthereon including a read only memory area containing a unique serialnumber, which may for example be embedded at the time of manufacture; aread/write memory area which can be made read only once information hasbeen written thereto; and a password protected memory area containingdata in encrypted form which data may be of anti-counterfeiting utility.

The tag may be associated with the medicament container in any suitablefashion. In one aspect, the tag is somehow attached or fixed to themedicament container by any suitable means including adhesive fixing,welding, snap-fit arrangements or through the use of various mountingmeans. The mounting means may for example, comprise an adhesive label,wrap-round tape or collar arrangement.

In another aspect, the tag is located within the medicament container,for example, as a loose component together with any medicament contentsthereof or within a separate compartment or housing within themedicament container. An advantage of placing the tag within themedicament container is that is can be ‘hidden from view’ therebyimproving its utility as a security feature. Additionally, the tag andcontainer may be configured (e.g. shaped and sized) such that the tagmay only be removed by rupture or other degradation of the medicamentcontainer or tag.

Suitably, the tag is on a carrier and the carrier is mountable on thehousing or the medicament container.

In one aspect, the carrier is a flexible label. In another aspect, thecarrier is a rigid disc. In a further aspect, the carrier is arectangular block. In a further aspect, the carrier is a collar (e.g. inthe form of a ring) suitable for receipt by (e.g. for mounting to) themedicament container. Other shapes of carrier including those definingchip housings or enclosures are also envisaged.

Suitably, the carrier is mouldable or weldable to the medicamentcontainer or housing.

Suitably, the carrier encases the tag. More preferably, the carrierforms a hermetic seal for the tag.

In one aspect, the carrier comprises an insulating material such as aglass material or, a paper material, a ceramic material or an organicpolymeric material such as polypropylene.

Alternatively, the carrier includes a ferrite material.

The energy to power any transceiver may be in any suitable formincluding ultrasonic, infrared, radiofrequency, magnetic, optical andlaser form. Any suitable channels may be used to channel the energyincluding wave guide and fibre optic channels.

In one aspect, the second transceiver comprises a radiofrequencyidentifier comprising an antenna for transmitting or receivingradiofrequency energy; and an integrated circuit chip connecting withsaid antenna, and the first transceiver comprises a reader for saidradiofrequency identifier. In this case the radiofrequency identifier isa passive transceiver and the reader is an active transceiver. Anadvantage of radiofrequency identifier technology is that the readerneed not be in direct contact with the radiofrequency identifier tag orlabel to be read.

The radiofrequency identifier can be any known radiofrequencyidentifier. Such identifiers are sometimes known as radiofrequencytransponders or radiofrequency identification (RFID) tags or labels.Suitable radiofrequency identifiers include those sold by PhillipsSemiconductors of the Netherlands under the trade marks Hitag and Icode,those sold by Amtech Systems Corporation of the United States of Americaunder the trade mark Intellitag, and those sold by Texas Instruments ofthe United States of America under the trade mark Tagit.

Suitably, the antenna of the RFID tag is capable of transmitting orreceiving radiofrequency energy having a frequency of from 100 KHz to2.5 GHz. Preferred operating frequencies are selected from 125 KHz,13.56 MHz and 2.4 GHz.

In one aspect, the second transceiver comprises a magnetic label or tagcomprising an antenna for transmitting or receiving magnetic fieldenergy; and an integrated circuit chip connecting with said antenna, andthe first transceiver comprises a reader for said magnetic label or tag.In this case the magnetic label or tag is a passive transceiver and thereader is an active transceiver.

A suitable magnetic label or tag comprises plural magnetic elements inmutual association whereby the magnetic elements move relative to eachother in response to an interrogating magnetic field. A magnetic labelor tag of this type is described in U.S. Pat. No. 4,940,966. Anothersuitable magnetic label or tag comprises a magnetorestrictive elementwhich is readable by application of an interrogating alternatingmagnetic field in the presence of a magnetic bias field which results inresonance of the magnetorestrictive elements at different predeterminedfrequencies. A magnetic label of this type is described in PCT PatentApplication No. WO92/12402. Another suitable magnetic label or tagcomprising plural discrete magnetically active regions in a linear arrayis described in PCT Patent Application No. WO96/31790. Suitable magneticlabels and tags include those making use of Programmable MagneticResonance (PMR) (trade name) technology.

In another aspect, the second transceiver comprises a passivemicroelectronic memory chip and the first transceiver comprises anactive reader for said microelectronic memory chip. The microelectronicmemory chip may comprise an Electrically Erasable Programmable Read OnlyMemory (EEPROM) chip or a SIM card-type memory chip. In this case themicroelectronic memory chip is a passive transceiver and the reader isan active transceiver.

Any transceiver herein, particularly a passive transceiver may bemounted on or encased within any suitable inert carrier. The carrier maycomprise a flexible sheet which may in embodiments be capable ofreceiving printed text thereon.

In one aspect, the first transceiver is integral with the body such thata single unit is comprised. The first transceiver may for example beencased within or moulded to the body.

In another aspect, the first transceiver forms part of a base unit whichis reversibly associable with the body. The base unit may for example,form a module receivable by the body such as a snap-in module.

Suitably, the medicament dispenser additionally comprises an electronicdata management system, wherein the electronic data management system isin association with the first transceiver and/or second transceiver. Theelectronic data management system has input/output capability andcomprises a memory for storage of data; a microprocessor for performingoperations on said data; and a transmitter for transmitting a signalrelating to the data or the outcome of an operation on the data.

Suitably, the electronic data management system is arranged to beresponsive to or activated by the voice of a user. Thus, for example thesystem may be switched on or off in response to a voice command. In oneaspect, the electronic data management system is integral with the body.

In another aspect, the electronic data management system and firsttransceiver form part of a base unit which is reversibly associable withthe body.

Suitably, the medicament dispenser and/or medicament container isprovided with release means for releasing medicament from the medicamentcontainer.

In some embodiments, the release means needs to be primed to a releaseposition. A prime detector may therefore be provided to detect movementof the release means to the actuation position.

An example of a release means having a priming step is where themedicament dispenser comprises a reservoir of medicament product (e.g.in dry powder form) and the priming step involves movement of a measureddose from the reservoir to the actuation position. Reservoir-basedinhalation devices are for example, well known in the art.

Suitably, the medicament dispenser additionally comprises an actuationdetector for detecting actuation of the release means wherein saidactuation detector transmits actuation data to the electronic datamanagement system.

Suitably, the medicament dispenser additionally comprises a safetymechanism to prevent unintended multiple actuations of the releasemeans. The patient is thereby protected from inadvertently receivingmultiple doses of medicament in a situation where they take a number ofshort rapid breaths. More preferably, the safety mechanism imposes atime delay between successive actuations of the release means. The timedelay is typically of the order of from three to thirty seconds.

An example of a release means having a priming step is where themedicament dispenser comprises an energy store which is primed by theuser and arranged to release that energy on operation of a trigger. Therelease of the stored energy results in actuation of the medicamentrelease means. The energy store comprises in preferred aspects, abiasable resilient member such as a spring, a source of compressed fluidsuch as a canister of compressed gas or a battery. Chemical energysources are also suitable and might include chemical propellant orignition mixtures. Other sources might include physical explosives suchas liquefied or solidified gas in a canister which burst when heated orexposed to the atmosphere.

Breath-operable inhalers (Bols) are well-known examples of medicamentdispenser having a stored energy system and in which the triggercomprises a breath trigger which is triggered by the breath of thepatient. Known Bols are of the metered dose inhaler (MDI) type where themedicament container comprises an aerosol canister.

Suitably, the medicament dispenser additionally comprises a releasedetector for detecting release of medicament from the medicamentcontainer, wherein said release detector transmits release data to theelectronic data management system.

Suitably, any actuation detector, prime detector or release detectorcomprises a sensor for detecting any suitable parameter such asmovement. Any suitable sensors are envisaged including the use ofoptical sensors. The release detector may sense any parameter affectedby release of the medicament such as pressure, temperature, sound,moisture, and chemical factors such as carbon dioxide concentration oroxygen concentration, or the presence of released medicament orpropellant (e.g. via an ‘electronic nose’ sensor).

Suitably, the medicament dispenser additionally comprises a communicatorfor wireless communication with a network computer system to enabletransfer of data between the network computer system and the electronicdata management system. Preferably, the communicator enables two-waytransfer of data between the network computer system and the electronicdata management system.

Suitably, the data is communicable between the network computer systemand the electronic data management system in encrypted form. Allsuitable methods of encryption or partial encryption are envisaged.Password protection may also be employed. Suitably, the communicatoremploys radiofrequency or optical signals.

In one aspect, the communicator communicates via a gateway to thenetwork computer system. In another aspect, the communicator includes anetwork server (e.g. a web server) such that it may directly communicatewith the network.

In a further aspect, the communicator communicates with the gateway viaa second communications device. Preferably, the second communicationsdevice is a telecommunications device, more preferably a cellular phoneor pager. Preferably, the communicator communicates with the secondcommunications device using spread spectrum radiofrequency signals. Asuitable spread spectrum protocol is the Bluetooth (trade mark) standardwhich employs rapid (e.g. 1600 times a second) hopping between pluralfrequencies (e.g. 79 different frequencies). The protocol may furtheremploy multiple sending of data bits (e.g. sending in triplicate) toreduce the effects of external interference.

In one aspect, the network computer system comprises a public accessnetwork computer system. The Internet is one suitable example of apublic access network computer system, wherein the point of accessthereto can be any suitable entrypoint including an entrypoint managedby an Internet service provider. The public access network computersystem may also form part of a telecommunications system, which mayitself be either a traditional copper wire system, a cellular system oran optical network.

In another aspect, the network computer system comprises a privateaccess network computer system. The private access network system mayfor example, comprise an Intranet or Extranet which may for example, bemaintained by a health service provider or medicament manufacturer. Thenetwork may for example include password protection; a firewall; andsuitable encryption means.

Preferably, the communicator enables communication with a user-specificnetwork address in the network computer system.

The user-specific network address may be selected from the groupconsisting of a web-site address, an e-mail address and a file transferprotocol address. Preferably, the user-specific network address isaccessible to a remote information source such that information fromsaid remote information source could be made available thereto. Morepreferably, information from the user-specific network address can bemade available to the remote information source.

In one aspect, the remote information source is a medicament prescriber,for example a doctor's practice. Information transferred from themedicament prescriber may thus, comprise changes to prescriptiondetails, automatic prescription updates or training information.Information transferred to the medicament prescriber may comprisecompliance information, that is to say information relating to thepatient's compliance with a set prescribing programme. Patientperformance information relating for example, to patient-collecteddiagnostic data may also be transferred to the medicament prescriber.Where the dispenser is an inhaler for dispensing medicament for therelief of respiratory disorders examples of such diagnostic data wouldinclude breath cycle data or peak flow data.

In another aspect, the remote information source is a pharmacy.Information transferred from the pharmacy may thus, comprise informationrelating to the medicament product. Information sent to the pharmacy maythus include prescription requests which have been remotelypre-authorized by the medicament prescriber.

In a further aspect, the remote information source is an emergencyassistance provider, for example a hospital accident and emergencyservice or an emergency helpline or switchboard. The information maythus, comprise a distress or emergency assist signal which requestsemergency assistance.

In a further aspect, the remote information source is a manufacturer ofmedicament or medicament delivery systems. Information transferred tothe system may thus, comprise product update information. The system mayalso be configured to feed information back to the manufacturer relatingto system performance.

In a further aspect, the remote information source is a researchestablishment. In a clinical trial situation, information may thus betransferred relating to the trial protocol and information relating topatient compliance fed back to the research establishment.

In a further aspect, the remote information source is an environmentalmonitoring station. Information relating to weather, pollen counts andpollution levels may thus be made accessible to the system.

Suitably, the medicament dispenser additionally comprises a data inputsystem for user input of data to the electronic data management system.Preferably, the data input system comprises a man machine interface(MMI) preferably selected from a keypad, voice recognition interface,graphical user interface (GUI) or biometrics interface.

Suitably, the system additionally comprises a visual display unit fordisplay of data from the electronic data management system to the user.The display may for example, comprise a screen such as an LED or LCDscreen. More preferably the visual display unit is associable with thehousing.

Suitably, the medicament dispenser additionally comprises a datalink forlinking to a local data store to enable communication of data betweenthe local data store and the electronic data management system. Thedatastore may also comprise data management, data analysis and datacommunication capability.

The datastore may itself form part of a portable device (e.g. a handhelddevice) or it may be sized and shaped to be accommodated within thepatient's home. The datastore may also comprise a physical storage areafor storage of replacement medicament containers. The datastore mayfurther comprise a system for refilling medicament from a reservoir ofmedicament product stored therewithin. The datastore may further providean electrical recharging system for recharging any electrical energystore on the medicament dispenser, particularly a battery rechargingsystem.

The datalink may for example enable linking with a docking station, apersonal computer, a network computer system or a set-top box (e.g.television set-top box) by any suitable method including a hard-wiredlink, an infra red link or any other suitable wireless communicationslink.

Suitably, the electronic data management system includes a predictivealgorithm or look-up table for calculating the optimum amount ofmedicament to dispense.

Suitably, the memory on the electronic data management system includes adose memory for storing dosage data and reference is made to the dosememory in calculating the optimum amount of medicament to dispense.

Suitably, the medicament dispenser additionally comprises a selector forselecting the amount of medicament to dispense from said dispensingmechanism. In one aspect, the selector is manually operable. In anotheraspect, the selector is operable in response to a signal from thetransmitter on the electronic data management system.

Suitably, the medicament dispenser additionally comprises a geographicpositioning system such as a global positioning system or a system whichrelies on the use of multiple communications signals and a triangulationalgorithm.

In one aspect, the system is suitable for the delivery of respirablemedicament and additionally comprises a sensor which senses the breathof a user, wherein the sensor communicates breath data to the electronicdata management system.

In one aspect, the sensor comprises a breath-movable element which ismovable in response to the breath of a patient. More preferably, thebreath-movable element is selected from the group consisting of a vane,a sail, a piston and an impeller.

In another aspect, the sensor comprises a pressure sensor for sensingthe pressure profile associated with the breath of a user.

In a further aspect, the sensor comprises an airflow sensor for sensingthe airflow profile associated with the breath of a user.

In a further aspect, the sensor comprises a temperature sensor forsensing the temperature profile associated with the breath of a user.The temperature of the inhaled and exhaled part of the breath cyclevaries and may, thus, be used as a measurement tool.

In a further aspect, the sensor comprises a moisture sensor for sensingthe moisture profile associated with the breath of a user. The moisturecontent of the inhaled and exhaled part of the breath cycle varies andthis also may be used as a measurement tool.

In a further aspect, the sensor comprises a gas sensor for sensing theoxygen or carbon dioxide profile associated with the breath of a user.The chemical profile of the inhaled and exhaled part of the breath cyclevaries and this further may be used as a measurement tool.

Suitably, the breath data includes breath cycle data, FEV₁ and/or peakflow data.

Suitably, the medicament dispenser additionally comprises release meansfor releasing medicament from said medicament container; a breathtrigger for triggering the release means, said breath trigger beingactuable in response to a trigger signal from the electronic datamanagement system. Preferably, the electronic data management systemincludes a predictive algorithm or look-up table for deriving from thebreath data when to transmit the trigger signal. For example, areal-time analysis of the patient breath waveform may be made and thetrigger point derived by reference to that analysed waveform.

Suitably, the medicament container is an aerosol container. Suitably,the aerosol container comprises a suspension of a medicament in apropellant. Suitably, the propellant comprises liquefied HFA134a,HFA-227 or carbon dioxide. In one aspect, the aerosol containercomprises a solution of a medicament in a solvent.

Suitably, the medicament container is for the containment of medicamentin tablet or nebule form.

Suitably, the medicament container is a dry-powder container. In oneaspect, the container comprises a reservoir for dry powder medicamentwhich is accessible by a metering means for metering (e.g. a dose of)medicament therefrom. In another aspect, the medicament containercomprises one or individual capsules or blisters for containing definedamounts of powdered medicament. Multi-unit dose blisters in elongatestrip form are particularly envisaged.

Suitably, the dry-powder container comprises medicament and optionallyexcipient in dry-powder form.

Where the medicament container is an aerosol container the release meanstypically comprises a valve mechanism. Where the medicament containercomprises a dry powder reservoir the release means typically co-operateswith the aforementioned metering means for metering (e.g. a dose of)medicament therefrom. Where the medicament container comprises one ormore individual capsules or blisters the release means typicallycomprises means for rupturing, peeling apart or otherwise accessing thecontents thereof.

Suitably, the medicament is selected from the group consisting ofalbuterol, salmeterol, fluticasone propionate, ipratropium bromidebeclomethasone dipropionate, salts or solvates thereof and any mixturesthereof. Suitable combination products comprise salmeterol xinafoate andfluticasone propionate; or salmeterol and ipratropium bromide.

The medicament dispenser herein may also be in the form of a syringe.Traditional syringes rely on puncturing of the patient's skin by ahollow needle through which the injectable medicament (in solution orsuspension form) is delivered to the muscle or tissue of the patientfrom a medicament container (e.g. in the form of a syringe barrel).Recently developed needleless systems for the delivery of injectablesemploy high velocity injection of particle formulated drugs or vaccinethrough the skin and into any physically accessible tissue. Otherneedleless systems employ similar high velocity injection of drug orvaccine coated on to a suitable carrier particle. Such needlelesssystems may be configured to include a source of compressed air or gas,which on release provides energy to propel the medicament particles forinjection into the skin.

According to another aspect of the present invention there is provided akit of parts comprising a medicament dispenser comprising a body, saidbody shaped for receipt of a medicament container; in association withthe body, a first transceiver for transmitting and receiving data; and amedicament container receivable by the body of the medicament dispenser;and in association with the medicament container, a second transceiverfor transmitting and receiving data, wherein data is transferable intwo-way fashion from the first transceiver to the second transceiver.

In one aspect, the data is transferable in two-way fashion from thefirst transceiver to the second transceiver only when the medicamentcontainer is received within the body of the medicament dispenser.

In one aspect, the kit of parts is arranged such that the medicamentdispenser comprises parts which are reusable (i.e. typically expensive)and the medicament container comprises parts which are disposable (i.e.typically cheap) or recyclable.

In aspects, the medicament dispenser may therefore be arranged tocomprise reusable elements selected from the group consisting of anouter casing; a first transceiver; an electronic data management system;an electronic display; a rechargeable battery; and optionally varioussensors. The medicament container on the other hand is arranged tocomprise disposable/recyclable elements selected from the groupconsisting of a disposable medicament pack; a disposable battery; adisposable second transceiver; and optionally a disposablemouthpiece/release means.

According to another aspect of the present invention there is provided asystem comprising a medicament dispenser as described herein beforeincluding an electronic data management system; and a remote datamanagement system, wherein data is transferable between the electronicdata management system of the medicament dispenser and the remote datamanagement system. The term remote is used to mean that the remote datamanagement system forms part of a system or device which is separatefrom the medicament dispenser.

In one aspect, the remote data management system comprises a local datastore e.g. as described hereinbefore.

In another aspect, the remote data management system comprises a networkcomputer system e.g. as described hereinbefore.

BRIEF DESCRIPTION OF THE FIGURES

Embodiments according to the invention will now be described withreference to the accompanying drawings in which:

FIGS. 1 a and 1 b show representations of a metered dose inhaler hereinin assembled form and separated into its component parts of housing andaerosol container;

FIG. 2. shows a schematic representation of an electronic datamanagement system for use herein;

FIGS. 3 a and 3 b show a ring collar attachment for an aerosol containerfor use in a metered dose inhaler;

FIG. 4 shows a sectional view of an actuator housing suitable forreceiving an aerosol container with ring attachment as shown in FIGS. 3a and 3 b; and

FIGS. 5 a and 5 b show a medicament container herein in the form of anelongate blister strip.

DETAILED DESCRIPTION

FIGS. 1 a and 1 b show a metered dose inhaler comprising a tubularactuator housing 1 shaped for receipt of an aerosol container 2. Theactuator housing is open at one end and is closed at the other. Anoutlet 3 leads laterally from the closed end of the housing 1. In theembodiment illustrated, the outlet 3 is in the form of a mouthpieceintended for insertion into the mouth of the patient but it may, ifdesired, be designed as a nozzle for insertion into the patient'snostril. The aerosol container 2 has an outlet valve 4 at one end. Thisvalve acts as a release means for release of a measured dose from theaerosol container. The release means is actuable by inward movement ofthe valve 4 relative to the aerosol container 2.

The metered dose inhaler of FIGS. 1 a and 1 b includes an electronicdata management system 10 comprised within an extended part of thehousing 6. Visual display monitor 12 allows for display of informationfrom the electronic data management system 10 to the patient. Theelectronic data management system 10 connects to a sensor (not visible)for sensing the breathing pattern of the patient and an actuator (notvisible) for actuating the release of aerosol from the container 2.

A passive transceiver in the form of a tag 20 on an inert carrier 25 ismounted on the side of the aerosol container 2. An active transceiver inthe form of a reader 30 for the tag 20 is moulded into the internalsurface of the housing 1. The reader 30 is capable of data communicationwith the electronic data management system 10. The reader 30 is alsocapable of reading and writing information to the tag 20 mounted on theaerosol container 2 by transmission and receipt of energy to/from thetag 20 (shown as broken arrows).

In one embodiment the tag 20 comprises a radiofrequency identificationtag and the active transceiver 30 is capable of reading data therefromand writing data thereto by the use of interrogating radiofrequencyenergy. In another embodiment the tag 20 comprises a magnetic label andthe active transceiver 30 is capable of reading data therefrom andwriting data thereto by the use of interrogating magnetic field energy.

FIG. 2 shows the structure of an electronic data management 110comprised within the housing of a respiratory drug delivery system (notshown). The electronic data management system 110 could for example beemployed in the metered dose inhaler shown in FIGS. 1 a and 1 b. Thedata management system 110 comprises a central processor unit (CPU) 140,RAM 141 and ROM 142. The CPU 140 is capable of two-way data transferwith reader 130. The reader is capable of reading and writinginformation to a passive transceiver in the form of a tag 120 (e.g. on amedicament container). The tag 120 may comprise an RFID tag or amagnetic tag. As in FIGS. 1 a and 1 b. the reader 130 will form part ofthe housing of the drug delivery system and the tag 120 will be mountedon a reloadable medicament container receivable thereby. The CPU 140also receives patient data from sensor 150 which may for example be abreath sensor or a sensor detecting actuation of the drug deliverysystem. The received data is storable in data storage device 143 whichincludes two databases, one for storage of medical data 143 a and onefor storage of personal patient data 143 b. The CPU 140 is alsoassociated with man machine interface 144 for receipt of patient inputcommands; clock 145; and display driver 111 and display 112 for displayof information to the patient. The CPU 140 is further associated withcommunications port 155 which links via modem 156 to a network computersystem (not shown) to enable communication therewith.

FIGS. 3 a and 3 b show a collar ring 260 which is shaped for attachmentto the neck of an aerosol container 202 (shown in FIG. 3 a only) havinga dispensing stem 204 for use in a metered dose inhaler. The collar ringincludes weld ring 264 for welding the collar 260 to the aerosolcontainer 202. The collar ring also includes passive transceiver in theform of an electrically erasable programmable read only memory (EEPROM)chip 220. The chip 220 communicates with electrical contact pad 225.

FIG. 4 shows an actuator housing 301 in the form of a metered doseinhaler shaped for receipt of aerosol container 302 having a collar ring360 (as shown in FIGS. 3 a and 3 b). The housing has an outlet in theform of a mouthpiece 303 and an actuator block with dispensing nozzle305 shaped for receipt of the valve stem 304 of the aerosol container.The rear part of the housing 301 is extended 306 to accommodate anelectronic data management system 310 (not shown in detail). Passivetransceiver 320 in the form of EEPROM on the collar ring 360communicates with the data management system 310 via electrical contact325. The data management system 310 includes a reader for the passivetransceiver 320. Data may therefore be transferred in read/write fashionbetween the electronic data management system 310 and the passivetransceiver 320.

FIGS. 5 a and 5 b show a medicament container 402 in the form of anelongate strip comprising a blister 404 for containment of powderedmedicament. Whilst for simplicity only one blister 404 is shown it willbe appreciated that variations could comprise multiple blisters (e.g.arranged in axial fashion). As visible in FIG. 5 b, the reverse of theblister 404 is provided with a tag 420 in the form of an electronicmemory chip. In one aspect, power is supplied to the chip 420 by meansof electrical contacts 422 b, 422 a in communication with electricalinputs 424 a, 424 b. The chip 420 connects with antenna 425 whichenables transfer of energy/data to the chip 420.

The blister strip 402 of FIGS. 5 a and 5 b is designed for receipt by amedicament dispenser (not shown) for which it would comprise amedicament refill pack. Multi-unit dose blister type dispensers for drypowder medicament are known in the art, including the device sold byGlaxoSmithKline under the trade mark Diskus as for example described inU.S. Pat. No. 6,032,666.

The medicament dispenser of the present invention is in one aspectsuitable for dispensing medicament for the treatment of respiratorydisorders such as disorders of the lungs and bronchial tracts includingasthma and chronic obstructive pulmonary disorder (COPD).

Appropriate medicaments may thus be selected from, for example,analgesics, e.g., codeine, dihydromorphine, ergotamine, fentanyl ormorphine; anginal preparations, e.g., diltiazem; antiallergics, e.g.,cromoglycate (e.g. s the sodium salt), ketotifen or nedocromil (e.g. asthe sodium salt); antiinfectives e.g., cephalosporins, penicillins,streptomycin, sulphonamides, tetracyclines and pentamidine;antihistamines, e.g., methapyrilene; anti- inflammatories, e.g.,beclomethasone (eg as the dipropionate ester), fluticasone (e.g. as thepropionate ester), flunisolide, budesonide, rofleponide, mometasone e.g.as the furoate ester), ciclesonide, triamcinolone (e.g. as theacetonide) or 6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioicacid S-(2-oxo-tetrahydro-furan-3-yl) ester; antitussives, e.g.,noscapine; bronchodilators, e.g., albuterol (eg as free base orsulphate), salmeterol (eg as xinafoate), ephedrine, adrenaline,fenoterol (eg as hydrobromide), formoterol (eg as fumarate),isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine,pirbuterol (eg as acetate), reproterol (eg as hydrochloride), rimiterol,terbutaline (eg as sulphate), isoetharine, tulobuterol or4-hydroxy-7-[2-[[2-[[3-(2-phenylethoxy)propyl]sulfonyl]ethyl]amino]ethyl-2(3H)-benzothiazolone;adenosine 2a agonists, eg2R,3R,4S,5R)-2-[6-Amino-2-(1S-hydroxymethyl-2-phenyl-ethylamino)-purin-9-yl]-5-(2-ethyl-2H-tetrazol-5-yl)-tetrahydro-furan-3,4-diol(e.g. as maleate); α₄ integrin inhibitors eg(2S)-3-[4-({[4-(aminocarbonyl)-1-piperidinyl]carbonyl}oxy)phenyl]-2-[((2S)-4-methyl-2-{[2-(2-methylphenoxy)acetyl]amino}pentanoyl)amino] propanoic acid (e.g as free acid orpotassium salt), diuretics, e.g., amiloride; anticholinergics, e.g.,ipratropium (eg as bromide), tiotropium, atropine or oxitropium;hormones, e.g., cortisone, hydrocortisone or prednisolone; xanthines,e.g., aminophylline, choline theophyllinate, lysine theophyllinate ortheophylline; therapeutic proteins and peptides, e.g., insulin orglucagon; vaccines, diagnostics, and gene therapies. It will be clear toa person skilled in the art that, where appropriate, the medicaments maybe used in the form of salts, (e.g., as alkali metal or amine salts oras acid addition salts) or as esters (e.g., lower alkyl esters) or assolvates (e.g., hydrates) to optimise the activity and/or stability ofthe medicament.

Preferred medicaments are selected from albuterol, salmeterol,fluticasone propionate and beclomethasone dipropionate and salts orsolvates thereof, e.g., the sulphate of albuterol and the xinafoate ofsalmeterol.

Medicaments can also be delivered in combinations. Preferredformulations containing combinations of active ingredients containsalbutamol (e.g., as the free base or the sulphate salt) or salmeterol(e.g., as the xinafoate salt) or formoterol (eg as the fumarate salt) incombination with an anti-inflammatory steroid such as a beclomethasoneester (e.g., the dipropionate) or a fluticasone ester (e.g., thepropionate) or budesonide. A particularly preferred combination is acombination of fluticasone propionate and salmeterol, or a salt thereof(particularly the xinafoate salt). A further combination of particularinterest is budesonide and formoterol (e.g. as the fumarate salt). Afurther combination of particular interest is salmeterol, or a saltthereof (particularly the xinafoate salt) and ipratropium bromide.

The medicament dispenser of the present invention is in another aspect asyringe for the delivery of injectable medicament to a patient.Traditional syringes rely on puncturing of the patient's skin by ahollow needle through which the injectable medicament (in solution orsuspension form) is delivered to the muscle or tissue of the patient.Recently developed needleless systems for the delivery of injectablesemploy high velocity injection of particle formulated drugs or vaccinethrough the skin and into any physically accessible tissue. Otherneedleless systems employ similar high velocity injection of drug orvaccine coated on to a suitable carrier particle.

It will be understood that the present disclosure is for the purpose ofillustration only and the invention extends to modifications, variationsand improvements thereto.

The application of which this description and claims form part may beused as a basis for priority in respect of any subsequent application.The claims of such subsequent application may be directed to any featureor combination of features described therein. They may take the form ofproduct, method or use claims and may include, by way of example andwithout limitation, one or more of the following claims:

1. A dry powder medicament inhaler comprising: a. an inhaler housing, said inhaler housing shaped for receipt of a container of inhalable dry powder medicament, and in association with the inhaler housing, a first transceiver for transmitting and receiving data; said first transceiver comprising a reader, and b. a container of inhalable dry powder medicament receivable by the inhaler housing; and in association with the container of inhalable dry powder medicament, a second transceiver for transmitting and receiving data, wherein the second transceiver comprises a tag, said tag being readable by said reader, and said tag comprising: an antenna for transmitting or receiving energy; and an integrated circuit chip connected with said antenna, wherein the integrated circuit chip comprises  a memory area, wherein data is transferable in two-way fashion from the first transceiver to the second transceiver in the absence of direct physical contact between the first and second transceiver.
 2. The dry powder medicament inhaler of claim 1, wherein said memory area comprising a restricted read access.
 3. The dry powder medicament inhaler of claim 1, wherein said memory area comprises a read/write memory area.
 4. The dry powder medicament inhaler of claim 1, wherein said memory area comprises a one-time programmable memory area.
 5. The dry powder medicament inhaler of claim 1, wherein said memory area comprises a preset memory containing a non-changeable data item.
 6. The dry powder medicament inhaler of claim 1, wherein said memory area comprises plural memory areas.
 7. A dry powder inhaler according to claim 1, wherein the memory area comprises a one time programmable memory area, and said one time programmable memory area contains a unique serial number.
 8. The dry powder medicament inhaler of claim 1, wherein said memory area of said integrated circuit chip contains data in encrypted form.
 9. The dry powder medicament inhaler of claim 1, wherein said memory area of said integrated circuit chip is password protected.
 10. The dry powder medicament inhaler of claim 1, wherein the second transceiver comprises a passive microelectronic memory chip, and the first transceiver comprises an active reader for said microelectronic memory chip.
 11. A dry powder medicament inhaler comprising: a. an inhaler housing, said inhaler housing shaped for receipt of a container of inhalable dry powder medicament, and in association with the inhaler housing,  a first transceiver for transmitting and receiving data; said first transceiver comprising a reader, and b. a container of inhalable dry powder medicament receivable by the inhaler housing; and in association with the container of inhalable dry powder medicament,  a second transceiver for transmitting and receiving data, wherein the second transceiver comprises a tag, said tag being readable by said reader, and said tag comprising:  an antenna for transmitting or receiving energy; and  an integrated circuit chip connected with said antenna,  wherein the integrated circuit chip comprises a memory area, said memory area comprising plural memory areas including: (a) a read only memory area containing a unique serial number; (b) a read/write memory area which can be made read only; and (c) a password protected memory area containing data in encrypted form wherein data is transferable in two-way fashion from the first transceiver to the second transceiver in the absence of direct physical contact between the first and second transceiver.
 12. The dry powder medicament inhaler of claim 11, wherein the second transceiver comprises a passive microelectronic memory chip and the first transceiver comprises an active reader for said microelectronic memory chip.
 13. The dry powder inhaler of claim 1, wherein said container of inhalable dry powder medicament comprises an elongate strip of containing individual doses of inhalable medicament.
 14. The dry powder inhaler of claim 11, wherein said container of inhalable dry powder medicament comprises an elongate strip of containing individual doses of inhalable medicament. 